Medicinal products; application for certification according to good manufacturing practice or good distribution practice

Certification according to Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) is required if, for example, companies wish to manufacture or market medicinal products on a professional or commercial basis. It is carried out following the inspections required under Section 64 of the German Medicines Act.

Description

Within 90 days of an inspection to verify Good Manufacturing Practice or Good Distribution Practice, a certificate shall be issued to the inspected establishments, facilities or persons if the inspection has led to the conclusion that the relevant principles and guidelines are complied with.

Prerequisites

The GMP/GDP certificate is issued if the inspection has not revealed any critical or serious defects/errors.

Procedure

The inspections were planned and carried out by the competent government. Other authorities are involved ex officio if necessary.

Deadlines

none

Processing time

The certificate is issued within the statutory period of 90 days after the inspection if there are no critical or serious defects/faults.

Fees

  • Costs for the issuance of a certificate: 100 EUR (according to cost schedule - tariff no. 7.IX.8 /tariff item 2.4).

    Expenses (e.g. inspection costs, travel expenses) depend in particular on the time required.

    They are to be borne by the institution/company to be certified.

Remedy

Administrative court proceedings; information

Administrative court action

Status: 11.10.2021

Responsible for editing: Bayerisches Staatsministerium für Gesundheit und Pflege

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